Collagen P.I.N.
The Collagen P.I.N. microneedling cartridge contains 36 stainless-steel needles in a radial array. It connects to the system's powered handpiece, which reciprocates the array to create…
The Collagen P.I.N. microneedling cartridge contains 36 stainless-steel needles in a radial array. It connects to the system’s powered handpiece, which reciprocates the array to create small skin injuries. Needle penetration depth is adjusted at the handpiece from 0 to 3 mm.
The needles are 35 gauge and 3 mm long, with tapered tips. A polycarbonate shell and piston house the array. A silicone boot connects the array to the cartridge shell and acts as a spring, while the housing limits liquid entry toward the handpiece motor.
Listed Item
100 Pack – 36 Pin Microneedling Cartridge
Use and Supply
Cartridges are individually packaged and sterilized with ethylene oxide for disposal after use. The associated system is indicated to improve facial acne scar appearance in adults aged 22 or older with Fitzpatrick skin types I to III. The cartridge is the disposable needling component rather than the motorized handpiece.
Who Else Makes It
Concentrated in Beijing (4), Guangdong (4), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Guangzhou Ekai Electronic Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Guangdong Carain Beauty Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Induction Therapies, LLC, United States |
|---|---|
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K222199 |
| Record published | 2023-02-03 |
| Record revised | 2023-11-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-02-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ellacor | Cytrellis Biosystems, Inc. | 25 |
| Footswitch | Mt.derm GmbH | 5 |
| SkinPen Precision Elite | Bellus Medical, LLC | 4 |
| Exceed | Mt.derm GmbH | 4 |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | Mt.derm GmbH | 3 |
| SkinPen Precision Treatment Kits | Bellus Medical, LLC | 3 |
| CytoPen S2 | Emage Medical, LLC | 3 |
| Dp4 | Equipmed USA B.V. | 3 |
| PRO Pen Microneedling System | Dermalogica, LLC | 1 |
| Xcellarispro Twist Control unit | Dermaroller GmbH | 1 |
| Eclipse EVO Microneedling Cartridge | Eclipse, Inc. | 1 |
| Eclipse MicroPen EVO | Eclipse, Inc. | 1 |
Showing 12 of 43. All products under Powered Microneedle Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222199 | 2022-10-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.